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SCHOOL OF PHARMACY
SCHOOL OF PHARMACY
PHARMACY REGULATORY AFFAIRS

Detailed course offerings (Time Schedule) are available for

PHRMRA 524 Introduction to Clinical Trials (3) Hammond, Hayashi, Jonlin
Introduces the major concepts under which clinical trials are designed to run. Focuses on the phases of clinical trials, the role of the Food and Drug Administration, Institutional Review Boards, the Code of Federal Regulations and ethical principles. Addresses study design and statistical concepts. Offered: A.
MyPlan Course Details: PHRMRA 524 (student access only)

PHRMRA 525 Implementation and Conduct of Clinical Trials (3) Hammond, Hayashi, Jonlin
Outlines the work of carrying out a clinical trial including the complex work of study initiation, issues of site and data managements, preparation of the final report and study close out, as well as the details that control the study conduct. Offered: W.
MyPlan Course Details: PHRMRA 525 (student access only)

PHRMRA 526 Project Management and the Business of Clinical Trials (3) Hammon, Hayashi, Jonlin
Addresses the business dimension of clinical trials, including the principles of project management, planning, analysis, contingency and follow-up within the context of clinical trials that involve a large number of tasks and people responsible for parts of the overall study. Offered: Sp.
MyPlan Course Details: PHRMRA 526 (student access only)

PHRMRA 527 International Regulatory Affairs (3) Hammond
Develops an understanding of international differences in the regulation of design, manufacture, and post-marketing surveillance of medical products relative to U.S. Food and Drug Administration requirements. Prerequisite: PHARM 504. Offered: A.
MyPlan Course Details: PHRMRA 527 (student access only)

PHRMRA 528 Medical Risk Analysis and Management (3) Karp
Examines the principles and application of risk management methods in the design, manufacture, and marketing of medical products. Offered: W.
MyPlan Course Details: PHRMRA 528 (student access only)

PHRMRA 536 Skills for the Regulatory Affairs Professional (2) Rose
Covers essential skills in regulatory affairs and includes an overview of local medical products companies. Offered: A.
MyPlan Course Details: PHRMRA 536 (student access only)

PHRMRA 545 Data Essentials and Analysis for Regulatory Professionals (3) Magee
Applies statistical methods to medical products design, clinical evaluation, manufacturing, and post-marketing surveillance. Prerequisite: introductory statistics. Offered: W.
MyPlan Course Details: PHRMRA 545 (student access only)

PHRMRA 546 Technical Writing for the Medical Products Industries (3) Teal
Presents up-to-date information and strategies for effective technical communication within the medical product industries. Addresses the appropriate and correct use of the English language, information design, and the use of computer technology in producing professional documents. Emphasizes communicating technical information to a variety of stakeholders. Offered: A.
MyPlan Course Details: PHRMRA 546 (student access only)

PHRMRA 547 Advanced Topics in Medical Products Regulation (2, max. 6) Feagin
Addresses essential topics in medical products regulation. Employs a combination of lecture presentations, case studies, and participants' small group discussion to achieve practical outcomes for regulatory professionals. Offered: W.
MyPlan Course Details: PHRMRA 547 (student access only)

PHRMRA 548 Biomedical Regulatory Affairs Practicum ([1-9]-, max. 9) Feagin
Provides a practical experience to ensure that participants are able to shepherd new medical products (drug, device, biologic) through regulatory, clinical, and quality assurance aspects. Includes a project and final report. Offered: AWSpS.
MyPlan Course Details: PHRMRA 548 (student access only)

PHRMRA 550 Advanced Technical Writing for Biomedical Regulatory Affairs (2) Teal
Further examines communications with attention to best written practices. Provides an intensive review of common editing and advanced strategies for crafting highly reliable and effective documentation. Prerequisite: PHRMRA 546 or permission of instructor. Credit/no-credit only. Offered: Sp.
MyPlan Course Details: PHRMRA 550 (student access only)

PHRMRA 554 Advanced Medical Products Regulation I (2) Hammond
Provides an in-depth exploration of regulatory issues primarily related to non-clinical and clinical aspects of medical product development. Offered: A.
MyPlan Course Details: PHRMRA 554 (student access only)

PHRMRA 555 Advanced Medical Products Regulation II (2) Feagin
Provides an in-depth exploration of regulatory issues primarily related to manufacturing, post-marketing concerns, and FDA interactions. Offered: W.
MyPlan Course Details: PHRMRA 555 (student access only)

PHRMRA 560 Short Course in Multinational Biomedical Regulatory Affairs (2, max. 30) Hazlet
Presents three medical products registration countries or groupings (for instance, European Union, World Health Organization). Locale based on program impact, unique features, or recent or controversial regulatory issues.
MyPlan Course Details: PHRMRA 560 (student access only)

PHRMRA 595 Special Topics in Regulation (1-6, max. 24)
Offered: AWSpS.
MyPlan Course Details: PHRMRA 595 (student access only)